Court Throws Out PhRMA Lawsuit on Drug Importation

The DC District Court has dismissed for lack of standing a Pharmaceutical Research and Manufacturers of America (PhRMA)-led lawsuit that sought to block HHS and FDA from implementing a program to permit the importation of some drugs from Canada. The 12/2020 suit had asked the court to hold unlawful, set aside, and permanently enjoin implementation of the agencies’ proposed certification and final rule. PhRMA was joined in the lawsuit by Partnership for Safe Medicines and the Council for Affordable Health Coverage.

Under the HHS/FDA plan, which was rolled out during the Trump Administration, pharmacists and drug wholesalers, acting under state-sponsored programs, could import certain prescription drugs from Canada into the U.S. without drug manufacturers’ authorization or oversight, the groups said in a joint statement. Their complaint says that the final rule disregards key protections of the Federal Food, Drug, and Cosmetic Act that are designed to ensure patient safety. They note that a section of the act permits some drug importation, but only after the HHS secretary has certified that such importation (1) poses no additional risk to the public’s health and safety and (2) results in a significant reduction in the cost of covered products to the American consumer.

The lawsuit also argued that the final rule made conclusory statements as to safety and cost savings in HHS’ “certification,” but it contained no supporting evidence and “punted” the responsibility for safety and cost savings to state governments. The groups also said there is no indication that the final rule will reduce costs to actual American patients. They noted that in the preamble to both the proposed and final rule, HHS acknowledged that it cannot quantify the savings, if any, that would result from its rule.

At the time of the lawsuit, only Florida and New Mexico had submitted proposals to import Canadian drugs, and a handful of other states had acknowledged interest in participating.

In its decision, the court found that because no importation program has yet been approved, the plaintiffs and their members do not face “a concrete risk of harm from the inchoate importation program, as is required when suing. So the Court must dismiss this case for lack of standing.”